USPTO Patents Application 09993647

''iN^feEiWNjt^fiD STATES PATENT AND TRADEMARK OFFICE

In re Application of : Bemd RIEDL et al.
Serial No.: 09/993,647
Filed: November 27, 2001

im

Group Art Unit: 1624
Examiner: Deepak R. RAO

For: co-CARBOXYARYL SUBSTITUTED DIPHENYL UREAS AS RAF KINASE
INHIBITORS

INFORMATION DISCLOSURE STATEMENT UNDER 37 CFR §g 1.56, 1.97 and 1.98

Commissioner for Patents

P.O. Box 1450

Alexandria, VA 22313-1450

Sir:

This information disclosure statement is made in accordance with 37 C.F.R. §§ 1 .56, 1 .97
and 1.98 as follows:

Timing and Fees

I I Under 37 C.F.R. § 1.97(b), no fee or statement is required for filing this information
disclosure statement is filed:

I I witiiin three months of the filing date of a national application other than a CPA
under § 1.53(d);

I I within three months of the actual filing date of the national phase of a PCT
application; OR

I I before the mailing of a first substantive office action (including after filing of an
RCE).

Under 37 C.F.R. § 1 .97(c), this information disclosure statement is filed after the periods
specified in 37 C.F.R. § 1.97(b), but before the mailing date of:

XI a final rejection under 37 C.F.R. 1.113;

XI termination of prosecution, e.g. Ex Parte Quayle, M.P.E.P § 609(B)(2);

OR

a notice of allowance under 37 C.F.R. § 1 .3 1 1 ; and

05/10/2004 WBLftHCO 0OOOO0M 09993M7

01 FC:ia06 W- 00 *

DOCKET NO. BAYER-0018-A

is accompanied by:

I I the statement as specified in 37 C.F.R. § 1.97(e) set out below; OR

3 a check covering the fee of $180.00 under 37 C.F.R. § 1.17(p).

i 1 Under 37 C.F.R. § 1 .97(d), this information disclosure statement is filed after the mailing

date of the following actions which have not been withdrawn:

□ a final action under 37 C.F.R. § 1.1 13;

I I termination of prosecution, e.g. Ex Parte Quayle, M.P.E.P § 609(B)(2);
OR

I I a notice of allowance under 37 C.F.R. § 1.311;

AND is filed on or before payment of the issue fee; AND is accompanied by:

I I the statement as specified in 37 C.F.R. § 1.97(e) as set forth below, and
the fee of $180.00 under 37 C.F.R. § 1.1 7(p).

Statements Under 37 C.F.R. 1.97(e)

I I Each item of information contained in this information disclosure
statement was cited in a communication from a foreign patent office in a
counterpart foreign application having a mailing date not more than three
months prior to the filing date of this information disclosure statement; or

I I No item of information contained in this information disclosure statement
was cited in a communication from a foreign patent office in a counterpart
foreign application, and to the knowledge of the undersigned attorney
after making reasonable inquiry, no item of information contained in this
information disclosure statement was known to any individual designated
in 37 C.F.R. § 1.56(c) more than three months prior to the filing date of
the information disclosure statement.

Cited Materials

I I Copies of materials listed but not attached were cited in benefit (35 U.S.C. § 120)

ancestor application Serial No. , on Form 892 by the Examiner and/or Form

1449 by the applicant; see 37 C.F.R. § 1.98(d).

XI Copies of materials listed but not attached are on the attached diskette.

[X] Copies of the materials listed are attached (except for the foregoing).

2

DOCKET NO. BAYER-0018-A

Non-English Language References

I I An English-language search report or equivalent paper from a foreign patent
office is provided indicating the relevance of the cited reference(s).

I I A foreign-language search report from a foreign patent office is provided, and
pertinent parts are translated substantively below:

X = document of particular relevance when it is taken alone
Y = document of particular relevance when it is combined with another such
document

A = document defining the general state of the art
O = non-written disclosure
P = intercalated document

T = document cited to understand the theory or principle underlying the
invention

E = patent document which has the benefit of a date earlier than the filing date

and which was published only on or after this filing date
D = cited in the application
L = cited for another reason
& = publication of member of same patent family

I I Translation of other relevant information on foreign search report

[insert necessary translation here]

Other Information

Payment of Fees Due (If Any) :

3 A check for $180.00 covering the fee identified above is attached.

I I Please charge to Deposit Account No. 13-3402 $ for the fee identified above.

3

DOCKET NO. BAYER-0018-A

XI The Commissioner is hereby authorized to charge or credit any overpayment to Deposit
Account #13-3402, two copies of this paper are attached for this purpose.

Richard J. Traverso, Reg. No. 30,595
Attorney/Agent for Applicants

MILLEN, WHITE, ZELANO

& BRANIGAN, P.C.
Arlington Courthouse Plaza 1
2200 Clarendon Blvd. Suite 1400
Arlington, Virginia 22201
Telephone: (703) 243-6333
Facsimile: (703) 243-6410

Attorney Docket No.: BAYER-001 8-A

Date: May 5, 2004

RJT:jph

K:\BAYER\18A\Information Disclosure Statement.doc

CERTIFICATE OP MAILING

bw MtD in ■

) Box 1450,,,

I tarty oottty (tat Ob ocmtpondtnoe it fcetag deported w» «e
VS. Food Sovtcei a Fint Ch» Md to ■> envelope addrcacd He
Comroinioiwr of PMent* P O Box J4SO,, Alexmidri*. VA 22312-

Nose: EES ^ t^jng

Signature:.

4

DOCKET NO. BAYER-001 8-A

MAY 0 7 2004 J

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Substitute for form 1449A/PTO

Complete if Known

INFORMATION DISCLOSURE
STATEMENT BY APPLICANT

(use as many sheets as necessary)
of | 18

Application Number

Filing Date

First Named Inventor

Group Art Unit

Examiner Name

\Sheet 1

Attorney Docket Number

U.S. PATENT DOCUMENTS

Examiner
Initials *

Cite
No. 1

U.S. Patent Document
Kind Code 2

Number

(if known)

Name of Patentee or Applicant
of Cited Document

Date of Publication of
Cited Document
MM-DD-YYYY

Pages, Columns, Lines, Where Relevant
Passages or Relevant
Figures Appear

AA

502,504

U.S.

Thorns

08-01-1893

AF

2,649,476

U.S.

Martin

08-15-1953

AH

2,722,544

U.S.

Martin

11-01-1955

AK

2,797,214

U.S.

Werner Bossard

06-25-1957

BP

4,212,981

U.S.

Yukinaga et al.

07-15-1980

BQ

4,240,820

U.S.

Dickore et al.

12-23-1980

CV

5,447,957

U.S.

Adams et al.

09-05-1995

DH

5,886,044

U.S.

Widdowson et al.

03-23-1 999

Dl

5,891,895

U.S.

Shiraishi et al.

04-06-1999

DL

5,965,573

U.S.

Petrie et al.

10-12-1999

DM

6,004,965

U.S.

Breu et al.

12-21-1999

DN

6.005,008

U.S.

Widdowson et al.

12-21-1999

DP

6.020.345

U.S.

Vacher et al.

02-01-2000

DR

6,040,339

U.S.

Yoshida et al.

03-21-2000

DU

6,093,742

U.S.

Salituro et al.

07-25-2000

DV

6.133.319

U.S.

Widdowson

10-17-2000

DY

6,150,415

U.S.

Hammock et al.

11-21-2000

DZ

6,174,901 B1

U.S.

Mantlo et al.

01-16-2001

EA

6.178,399 B1

U.S.

Takebayashi et al.

01-23-2001

EB

6,180,675 B1

U.S.

Widdowson et al.

01-30-2001

EC

6.187,799 B1

U.S.

Wood et al.

02-13-2001

ED

6.211,373 B1

U.S.

Widdowson et al.

04-03-2001

EE

6,218,539 B1

U.S.

Widdowson

04-17-2001

EF

6.242.601 B1

U.S.

Breu et al.

06-05-2001

EG

6,262,113 B1

U.S.

Widdowson et al.

07-17-2001

EH

6,271,261 B1

U.S.

Widdowson

08-07-2001

El

6.333.341 B1

U.S.

Mantlo et al.

12-25-2001

EJ

6,339,045 B1

U.S.

Kanno etal.

01-15-2002

EK

6,344,476 B1

U.S.

Ranges et al.

02-05-2002

NW

4,546.191

U.S.

Nishiyama et al.

10-08-1985

NX

5,710,094

U.S.

Minami et al.

01-20-1998

NY

6,380,218

U.S.

Marfat et al.

04-30-2002

Examiner

Date

Signature

Considered

+

EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance
and not considered. Include copy of this form with next communication to applicant.

1 Unique citation designation number. 2 See attached Kinds of U.S. Patent Documents. 3 Enter Office that issued the document, by the two-letter code
(WIPO Standard ST.3). * For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the
patent document. 5 Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST. 1 6 if possible. 8 Applicant is
to place a check mark hee if English language Translation is attached.

Burden Hour Statement: This form is estimated to take 2.0 hours to complete. Time will vary depending upon the needs of the individual case. Any
comments on the amount of time you are required to complete this form should be sent to the Chief Information Officer, U.S. Patent and Trademark
Office, Washington, DC 20231. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Assistant Commissioner for
Patents, Washington, DC 20231 .

Please type a plus sign (+) inside this box

□

Under the Paperwork Reduction Act of 1995. no persons are requii

PTO/SB/08A (08-00) ,
Approved for use through 10/31/2002. OMB 0651-0031~y~
ylSrTatent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
respond to a colecfon of information unless it contains a valid OMB control number.

Substitute for form 1449A/PTO

INFORMATION DISCLOSURE
STATEMENT BY APPLICANT

(use as many sheets as necessary)

Complete if Known

Application Number

Filing Date

First Named Inventor

Group Art Unit

Examiner Name

Sheet

of 18

Attorney Docket Number

FOREIGN PATENT DOCUMENTS !

Examiner
Initials*

Cite
No.'

Foreign Patent Document

Name of Patentee or Applicant
of Cited Document

Date of Publication
of Cited Document
MM-DD-YYYY

Pages,
Columns,
Lines,
Where
Relevant
Passages or
Relevant
Figures
Appear

T 6

Office 3 Number 4 "j"* Codl f
(if known)

EM

90/02112

WO

The Nutrasweet Co.

03-08-1990

EY

96/10559

WO

Fujis WA Pharmaceutical Co.
Ltd.

04-11-1996

FD

97/17329

WO

Kirin Beer Kabushiki Kaisha

05-15-1997

FF

97/30992

WO

Bristol-Myers Squibb Co.

08-28-1997

FK

98/17267

WO

Zymogenetics, Inc.

04-30-1998

NZ

98/20868

WO

Picower Institute for Med. Res.

05-22-1 998

OA

98/45268

WO

Pfizer

10-15-1998

OB

02/14311

WO

Anger

02-21-2002

OC

02/92576

WO

Boehringer Ingelheim

11-21-02

OD

0690344 A1

EP

Konica Corp.

01-03-1996

FOREIGN PATENT DOCUMENTS

Examiner
Initials*

Cite
No.'

Foreign Patent Document

Name of Patentee or Applicant of
Cited Document

Date of
Publication of
Cited Document
MM-DD-YYYY

Pages,
Columns,

Lines,

Where
Relevant
Passages or
Relevant

Figures

T e i

Office 3 Number' Kind Code 5 (ff
known)

FZ

99/32437

WO

Slovako-Farma A.S.

07-01-1999

GG

00/43366

WO

Kirin Beer Kabushiki Kaisha

07-27-2000

GQ

0116932 A1

EP

BASF AG

08-29-1984

HD

0425443 A1

EP

CIBA-GEIGY AG

05-02-1991

HG

0202538 A1

EP

Bayer AG

11-26-1986

HH

0860433 A1

EP

Kirin Beer Kabushiki Kaisha

08-26-1998

HO

25 01 648 A1

DE

The Dow Chemical Co.

07-24-1975

HT

08-301841

JP

Green Cross Corp.

11-19-1996

HV

10-306078

JP

Mitsubishi Chemical Corp.

11-17-1998

Examiner

Date

Signature

Considered

EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance
and not considered. Include copy of this form with next communication to applicant.

' Unique citation designation number. 2 See attached Kinds of U.S. Patent Documents. 3 Enter Office that issued the document, by the two-letter code
(WIPO Standard ST.3). ' For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the
patent document. Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST. 1 6 if possible. 6 Applicant is
to place a check mark hee if English language Translation is attached.

Burden Hour Statement: This form is estimated to take 2.0 hours to complete. Time will vary depending upon the needs of the individual case. Any
comments on the amount of time you are required to complete this form should be sent to the Chief Information Officer, U.S. Patent and Trademark

+ Office, Washington, DC 20231. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Assistant Commissioner for
Patents, Washington, DC 20231.

Please type a plus sign (+) inside thi:

PTO/SB/08A (08-00)
Approved for use through 10/31/2002. OMB 0651-0031
U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
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Substitute for form 1449A/PTO

INFORMATION DISCLOSURE
STATEMENT BY APPLICANT

(use as many sheets as necessary)
V Sheet I 9

I of I 18

Complete if Known

Application Number

Filing Date

First Named Inventor

Group Art Unit

Examiner Name

Attorney Docket Number

OTHER PRIOR ART -- NON PATENT LITERATURE DOCUMENTS

Examiner
Initials *

Cite
No. 1

Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of

thp itpm /honk munsiyinp iniimsl Qprisl cvmrtncinm fatalnn ptr* ^ Hatp nnnp/e\ unlumo icciio

number(s), publisher, city and/or country where published.

IV

Abstract of EP 0405233A1, Tetsuo Sekiya et al.

JR

Grant, A.M. et al.: "Hypotensive thiadiazoles", J. Med. Chem. (1972), 15(10), pg. 1082-4.

JS

Russo, F. et al. "Synthesis of 2,6-substituted derivatives of 5H-1 ,3.4-thiadiazolo=3,2-a!-s triazine-5,7-dione"
FARMACO, ED.SCI. (1978), 33(12), 972-83

JT

Joseph T.Bruder et al., Journal of Virology. January 1997, "Adenovirus Infection Stimulates the Raf/MAPK

S ona no Pathway and Indupp^ Infprlpiikin-R f-vnrptcinn Uau 1T 1QQR nnc *%QR_dn4

JU

Foussard-Blanpin, Odette: "Comparative pharmacodynamic study of variously substituted carboxamides of the
central nervous ststem" Ann. Pharm. Fr. (1982), 40 (4), pgs. 339-350.

MP

Publication No. US 2001/0011136 A1, Publication Date: August 2, 2001, Riedl et al.

MQ

Publication No. US 2001/0016659 A1, Publication Date: August 23, 2001, Riedl et al.

MR

Publication No. US 2001/0027202 A1, Publication Date: October 4, 2001, Riedl etal.

MS

Publication No. US 2002/0165394 A1, Publication Date: November 7, 2002. Dumas et al.

MT

Publication No. US 2002/0042517 A1, Publication Date: April 11, 2002, Uday etal.

MU

Publication No. US 2001/0034447 A1 , Publication Date: October 25, 2001, Riedl et al.

MV

Publication No. US 2001/0011135 A1. Publication Date: August 2, 2001, Riedl et al.

MW

Publication No. US 2002/0103253 A1 , Publication Date: August 1 , 2002, Ranges et al.

Examiner
Signature

Date

Considered

+

EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance
and not considered. Include copy of this form with next communication to applicant.

1 Unique citation designation number. 2 Applicant is to place a check mark here if English language Translation is attached.

Burden Hour Statement: This form is estimated to take 2.0 hours to complete. Time will vary depending upon the needs of the individual case. Any
comments on the amount of time you are required to complete this form should be sent to the Chief Information Officer, U.S. Patent and Trademark
Office. Washington, DC 20231. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Assistant Commissioner for
Patents. Washington, DC 20231 .

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. „. PTO/SB/08A (08-00)

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\«__TR ADjiJ^s Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
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Substitute for form 1449A/PTO

INFORMATION DISCLOSURE
STATEMENT BY APPLICANT

(use as many sheets as necessary)

V Sheet | 17

Complete if Known

Application Number

Filing Date

First Named Inventor

Group Art Unit

Examiner Name

I of I 18

Attorney Docket Number

OTHER PRIOR ART - NON PATENT LITERATURE DOCUMENTS

Examiner
Initials *

Cite
No. 1

Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of
the item (book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue
number(s), publisher, city and/or country where published.

T 2

MX

Publication No. US 2001/OOOS975 A1, Publication Date: July 5, 2001, Wood et al.

MY

Publication No. US 2002/0062763 A1, Publication Date: May 30. 2002, Macholdt et al.

MZ

Publication No. US 2002/0085859 A1. Publication Date: July 4. 2002. Hashimoto et al.

NA

Publication No. US 2002/0085857 A1, Publication Date: July 4, 2002, Kim et al.

NB

Publication No. US 2002/0137774 A1, Publication Date: September 26, 2002, Riedl et al.

NC

Co-pending application Serial No. 09/640,780 filed August 18, 2000.

ND

Co-pending application Serial No. 09/472,232 filed December 27, 1999.

NE

Co-pending application Serial No. 09/776,936 filed December 22, 1998.

NF

Co-pending application Serial No. 09/776,935 filed December 22, 1998.

NG

Co-pending application Serial No. 09/993,647 filed November 27, 2001.

NH

Co-pending application Serial No. 10/086,417 filed March 4, 2002.

Nl

Co-pending application Serial No. 10/071,248 filed February 11, 2002.

NJ

Co-pending application Serial No. 10/308,187 filed December 3, 2002.

NK

Co-pending application Serial No. 10/361,859 filed February 11, 2003.

Examiner

Date

Signature

Considered

EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance
and not considered. Include copy of this form with next communication to applicant.

1 Unique citation designation number. 2 Applicant is to place a check mark here if English language Translation is attached.

Burden Hour Statement: This form is estimated to take 2.0 hours to complete. Time will vary depending upon the needs of the individual case. Any
comments on the amount of time you are required to complete this form should be sent to the Chief Information Officer. U.S. Patent and Trademark
Office, Washington, DC 20231. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Assistant Commissioner for
Patents, Washington, DC 20231 .

Please type a plus sign (+) inside this box

PTO/SB/08A (08-00)

r g t „ „c\\>>/ Approved for use through 10/31/2002. OMB 0651-0031

^iLXil^ii-^^.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number

4"

Substitute for form 1449A/PTO

INFORMATION DISCLOSURE
STATEMENT BY APPLICANT

(use as many sheets as necessary)

V Sheet | 18

Complete if Known

Application Number

Filing Date

First Named Inventor

Group Art Unit

Examiner Name

I of I 18

Attorney Docket Number

OTHER PRIOR ART - NON PATENT LITERATURE DOCUMENTS

Examiner
Initials *

Cite
No. 1

Inphifip namp nf thp aiithnr (irt ("CAPITA! I FTTFRS^ titlp nf thp artirMp ^ufhpn annrnnriatp^ titlp nf

II 1 lul 1 IC v/l 11 IC null IUI \tl 1 w#\l 1 1 HL L_ 1__ 1 1 ^1 \ W ) , IIIIC \i\ II IG CI 1 Llldc ^ VV 1 ICI 1 d^JfJI UfJI ICIIC^, LIIIC Ul

the item (book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue
number(s), publisher, city and/or country where published.

T 2

NL

Co-pending application Serial No. 10/361,844 filed February 11, 2003.

NM

Co-pending application Serial No. 10/361,850 filed February 11, 2003.

NN

Co-pending application Serial No. 10/060,396 filed February 1, 2002.

NO

Co-pending application Serial No. 09/458,014 filed December 10, 1999.

NP

Co-pending application Serial No. 10/125,369 filed April 19, 2002.

NQ

Co-pending application Serial No. 09/889,227 filed July 12. 2001.

NR

XP-001 145518 #4956 Potent Raf Kinase Inhibitors from the Diphenylurea Class: Structure Activity Relationships,
B. Riedl et al., Bayer Corporation.

NS

XP-001 145779 "Antitumor Activity of a C-raf Antisense Oligonucleotide in Combination with Standard
Chemotherapeutic Agents against Various Human Tumors Transplanted Subcutaneously into Nude Mice",
Thomas Geiger et al.. Vol. 3, 1 1 79-1 1 85, July 1 997.

NT

XP-001 145481 +2921 Phase I and Pharmacokinetic Study of the Raf Kinase Inhibitor Bay 43-9006 in Patients
with Locally Advanced or Metastic Cancer, Dirk Strumberg et al. Bayer AG.

NU

XP-0022321 30, "A Phase I Trial of H-ras Antisense Oligonucleotide ISIS 2503 Administered as a Continuous
Intravenous Infusion in Patients with Advanced Carcinoma", C. Casey Cunningham et al., 2001 American Cancer
Society, Volume 92, Number 5, pages 1265-1271.

NV

XP-002233466, MEDLINE/NLM, NLM8336809 - [Intra-arterial ACNU, CDDP chemotherapy for brain metastases
from lung cancer: comparison of cases with and without intra-arterial mannitol infusion], Iwadate Y et al.

OE

Journal of Immunological Methods Berwick 1996, vol. 196 (2) 163-173 corresponding to DN 125-245169

Examiner

Date

Signature

Considered

EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance
and not considered. Include copy of this form with next communication to applicant.

1 Unique citation designation number. 2 Applicant is to place a check mark here if English language Translation is attached.

Burden Hour Statement: This form is estimated to take 2.0 hours to complete. Time will vary depending upon the needs of the individual case. Any
comments on the amount of time you are required to complete this form should be sent to the Chief Information Officer, U.S. Patent and Trademark
Office, Washington. DC 20231. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Assistant Commissioner for
Patents, Washington. DC 20231 .